Status:
RECRUITING
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
American Heart Association
Conditions:
Nutrition
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutritio...
Detailed Description
This study is designed to test the feasibility and preliminary efficacy of a CGM-augmented FIM intervention for adults with type 2 diabetes and nutrition or food insecurity. The study will enroll adul...
Eligibility Criteria
Inclusion
- Able to complete study activities in English
- Aged ≥18 years
- Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes
- Chart review will be conducted by the study team and a diagnosis of type 2 diabetes (E.11.xx) from either the problem list or a diagnosis linked to an encounter will be used as confirmation. Discrepancies in diagnosis codes will be resolved by review of provider notes within the past 3 years.
- HbA1c \> 8.0% in the last 12 months via point of care or venous measurement. If there are multiple values, the most recent one will be considered.
- Receiving primary or specialty care within UNC Health as defined by at least one visit with a primary care provider or endocrine provider within the past year
- Indication of a barrier to healthy eating consisting of report of food insecurity (defined as a score greater or equal to 1.0 on the 6-item USDA Food Security Survey Module (FSSM)) and/OR nutrition insecurity (defined as more often than 'Rarely' on the One-Item Gretchen Swanson Nutrition Screener, OR more often than 'Not Very Hard' on the Two-item Nutrition Security Screener (NSS))
- Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS
- No plans to move from the area for at least 4 months
- Willing and able to provide written informed consent and participate in all study activities
Exclusion
- Type 1 or other diabetes
- Use of insulin or secretagogues in the preceding 6 months
- Use of CGM in the preceding 6 months
- Inability to use CGM and related technology (e.g., the companion app), including lack of a smartphone that is compatible with Stelo (information on compatible phones available in Appendix 1) or known allergy to adhesive
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Pregnancy or planned pregnancy in the next 4 months-glycemic targets are different for pregnant women compared to non-pregnant women with diabetes and our intervention is designed for non-pregnant glycemic targets
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07148713
Start Date
September 19 2025
End Date
June 1 2026
Last Update
November 12 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599